Thomas M Burton, Wall Street Journal: May 12, 2016
WASHINGTON—Moves in Congress to link billions of dollars in new medical research funds to revised standards for drug and medical-device approvals are troubling some public-health experts, who say the combination makes it too easy for lawmakers to support lower patient-safety standards.
These safety advocates say legislation to beef up research funding for the National Institutes of Health should be separated from product-approval changes at the Food and Drug Administration.
“This is the first time this has been done this way, and it’s a deal with the devil,” said Dr. David A. Kessler, onetime FDA commissioner during the 1990s under presidents of both parties. “It’s time to uncouple the promise of research funding from the requirement that FDA standards be lowered.”
The linkage was first made last July when the House passed a bill to ease FDA approvals of drugs and devices in ways broadly endorsed by the drug and device industry. That legislation carried a big infusion of cash for medical research—$8.75 billion for NIH and $550 million extra for the FDA, both over five years. The measure, called the 21st Century Cures Act, passed 344-77 with broad bipartisan support.
In the Senate, the leader of a parallel effort said he hopes to bring a package of 19 FDA and NIH bills to the floor soon—along with a separate measure on NIH funds. Sen. Lamar Alexander (R., Tenn.) chairman of the committee that approved the package, said finding the source of the funding is “the last remaining important issue” on the legislation, which he considers “the most important bill Congress considers this year.” […]
The new FDA commissioner, Dr. Robert M. Califf, said in a recent talk that “this legislation, if not carefully crafted, could pose significant risks for FDA and American patients…Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm,” he said.
Patient-advocacy groups like the National Center for Health Research and Public Citizen have said several bills now in Congress could jeopardize safety. […]
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